Nonalcoholic Fatty Liver DiseaseNAFLD-cohortNCT02422238
Prospective Cohort, With Biobanking, of Patients With Nonalcoholic Fatty Liver Disease
An observational study of Nonalcoholic Fatty Liver Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The aim of the present prospective NAFLD cohort study (with biobank), of obese subjects with proven NAFLD based on liver biopsy and/or MRI, is to study factors contributing to the development of NASH in patients with simple steatosis and to identify and validate non-invasive markers for the diagnosis of NASH. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease
- How many people
- 500 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2015to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese ( BMI ≥ 30 kg/m2) subjects with proven NAFLD either by imaging (using MRI) or histology, referred to secondary or tertiary care for obesity related problems will be asked to participate in this study.
Who may be able to join
- NAFLD diagnosis based on evidence of hepatic steatosis, either by imaging (using MRI) or by histology.
- BMI ≥ 30 kg/m2
- Between 18 - 65 years of age
Who cannot join
- Incompetent to understand and/or sign the informed consent.
- Causes for secondary hepatic fat accumulation such as significant alcohol consumption, medications, Wilson's disease, viral infections, starvation or parenteral nutrition, among others, and conditions associated with microvesicular steatosis
- Ethanol consumption exceeding more than 14 standard beverages per week for males and more than 7 standard beverages per week for female.
- Not able or willing to undergo MRI (for example claustrophobia, ICD, pacemaker).
- Not willing to be informed about unexpected findings by MRI
- Unwilling to collect bio samples.
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- Pregnancy and breastfeeding.
- Indication or planned for bariatric surgery within one year after inclusion or a history of bariatric surgery.
- Diagnosis of liver cirrhosis and/or hepatocellular carcinoma.
- Current diagnosis of extrahepatic malignancy(s) or prior diagnosis within last 5 years.
- Individuals about to undergo or recovering from a surgical or otherwise medical procedure that will interfere with data collection and analyses planned within the current cohort, will initially be excluded from participation, but are offered the opportunity to participate at a later moment in time
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Koek, MD, PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg
Koek, MD, PhD, 0031-43-3875021
About this study
Official title: Disease Mechanisms and Markers for Non-alcoholic Steatohepatitis in a Population With Non-alcoholic Fatty Liver Disease: a Prospective Cohort Study With Biobank
The aim of the present prospective NAFLD cohort study (with biobank), of obese subjects with proven NAFLD based on liver biopsy and/or MRI, is to study factors contributing to the development of NASH in patients with simple steatosis and to identify and validate non-invasive markers for the diagnosis of NASH.
Read the detailed description
Non-alcoholic fatty liver disease (NAFLD) is with 20-30% the most prevalent liver disorder in Western society. Most patients with NAFLD have no or few, mainly aspecific symptoms; and generally there is a silent progression of simple steatosis to NASH and in the end liver-related morbidity and mortality.
Further insight in factors contributing to the initiation of NASH in patients with simple steatosis and early diagnosis are essential for identifying future therapeutic options and to limit the risk of complicated NASH (i.e. fibrosis, and cirrhosis with portal hypertension) HCC, liver-related mortality and extrahepatic morbidity.
This cohort study, with both a cross-sectional and a longitudinal part, will include obese subjects (BMI ≥ 30 kg/m2, age 18-65) with proven NAFLD based on liver biopsy and/or MRI.
All participants will be asked to complete several questionnaires (i.e. demographics, clinical data, SF-36, GAD-7 and PHQ-9, FFQ, SQUASH, and Baecke), and to undergo anthropometric measurements. Furthermore, blood, urine, faeces and exhaled air will be collected and a fibroscan and DEXA-scan will be performed. Additionally, participants will be asked to participate in a multi-sugar test for intestinal permeability.
The majority of eligible subjects will undergo/have undergone a MRI or liver biopsy for clinical reasons. It is to be expected that about 33% of subjects will be asked to undergo a MRI for study purpose only.
After 5 and 10 years, participants will be invited to undergo in the same study procedures, data and sample collection to study the factors responsible for the development of NASH in the group with simple steatosis at baseline, and the development of (extra)hepatic complications in the group with NASH at baseline.
- Conditions
- Nonalcoholic Fatty Liver Disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of NASH
Measured: 10 years
Secondary outcomes (2)
Prevalence of hepatic complications of NAFLD
Measured: 10 years
Prevalence of extrahepatic complications of NAFLD
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Centrum Obesitas-Eetstoornissen (CO-EUR)
- Responsible party
- Principal investigator, Ger Koek, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422238
- Sponsor's protocol ID
- METC142074
- Acronym
- NAFLD-cohort
- Status last verified
- Sep 2016
- First submitted
- 16 Apr 2015
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Shami GJ, Samarska IV, Koek GH, Li A, Palma E, Chokshi S, Wisse E, Braet F. Giant mitochondria in human liver disease. Liver Int. 2023 Nov;43(11):2365-2378. doi: 10.1111/liv.15711. Epub 2023 Aug 24.
PubMed 37615254
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease Mechanisms and Markers for Non-alcoholic Steatohepatitis in a Population With Non-alcoholic Fatty Liver Disease: a Prospective Cohort Study With Biobank
- ClinicalTrials.gov ID
- NCT02422238
- Acronym / sponsor ID
- NAFLD-cohort / METC142074
- Conditions
- Nonalcoholic Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Centrum Obesitas-Eetstoornissen (CO-EUR)
- Study start
- Jun 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present prospective NAFLD cohort study (with biobank), of obese subjects with proven NAFLD based on liver biopsy and/or MRI, is to study factors contributing to the development of NASH in patients with simple steatosis and to identify and validate non-invasive markers for the diagnosis of NASH.
Detailed description
Non-alcoholic fatty liver disease (NAFLD) is with 20-30% the most prevalent liver disorder in Western society. Most patients with NAFLD have no or few, mainly aspecific symptoms; and generally there is a silent progression of simple steatosis to NASH and in the end liver-related morbidity and mortality.
Further insight in factors contributing to the initiation of NASH in patients with simple steatosis and early diagnosis are essential for identifying future therapeutic options and to limit the risk of complicated NASH (i.e. fibrosis, and cirrhosis with portal hypertension) HCC, liver-related mortality and extrahepatic morbidity.
This cohort study, with both a cross-sectional and a longitudinal part, will include obese subjects (BMI ≥ 30 kg/m2, age 18-65) with proven NAFLD based on liver biopsy and/or MRI.
All participants will be asked to complete several questionnaires (i.e. demographics, clinical data, SF-36, GAD-7 and PHQ-9, FFQ, SQUASH, and Baecke), and to undergo anthropometric measurements. Furthermore, blood, urine, faeces and exhaled air will be collected and a fibroscan and DEXA-scan will be performed. Additionally, participants will be asked to participate in a multi-sugar test for intestinal permeability.
The majority of eligible subjects will undergo/have undergone a MRI or liver biopsy for clinical reasons. It is to be expected that about 33% of subjects will be asked to undergo a MRI for study purpose only.
After 5 and 10 years, participants will be invited to undergo in the same study procedures, data and sample collection to study the factors responsible for the development of NASH in the group with simple steatosis at baseline, and the development of (extra)hepatic complications in the group with NASH at baseline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese ( BMI ≥ 30 kg/m2) subjects with proven NAFLD either by imaging (using MRI) or histology, referred to secondary or tertiary care for obesity related problems will be asked to participate in this study.
Key inclusion criteria (3 listed)
- NAFLD diagnosis based on evidence of hepatic steatosis, either by imaging (using MRI) or by histology.
- BMI ≥ 30 kg/m2
- Between 18 - 65 years of age
Key exclusion criteria (11 listed)
- Incompetent to understand and/or sign the informed consent.
- Causes for secondary hepatic fat accumulation such as significant alcohol consumption, medications, Wilson's disease, viral infections, starvation or parenteral nutrition, among others, and conditions associated with microvesicular steatosis
- Ethanol consumption exceeding more than 14 standard beverages per week for males and more than 7 standard beverages per week for female.
- Not able or willing to undergo MRI (for example claustrophobia, ICD, pacemaker).
- Not willing to be informed about unexpected findings by MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of NASH
Time frame: 10 years
2 secondary outcomes
Prevalence of hepatic complications of NAFLD
Time frame: 10 years
Prevalence of extrahepatic complications of NAFLD
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Derived from this study: PubMed 37615254Shami GJ, Samarska IV, Koek GH, Li A, Palma E, Chokshi S, Wisse E, Braet F. Giant mitochondria in human liver disease. Liver Int. 2023 Nov;43(11):2365-2378. doi: 10.1111/liv.15711. Epub 2023 Aug 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Koek, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonalcoholic Fatty Liver Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Koek, MD, PhD (0031-43-3875021), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of NASH (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02422238, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2016.